Long-Term Follow-Up and Management Patterns of Patients With Acute Coronary Syndrome in Middle East and Africa

NCT03362463 | Completed

• 1 other identifier: D1843R00256
• Study Type: observational
• Target: 1,191
• Locations: 1 country
• Sites: 1

Brief Summary

A multinational, prospective and observational study that will assess the management of ACS in real-life practices in Middle East North Africa area.

Conditions

Acute Coronary Syndrom

Outcome Measures

Primary Outcomes (4)

• Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns

  Prescription of Antithrombotic including Dual Antiplatelet(DAPT) Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

  1 Month

• Antihypertensive as apart of ACS Treatment patterns

  Prescription of Antihypertensive as apart of ACS Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

  1 Month

• Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM

  Prescription of Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

  1 Month

• Cholesterol lowering agents including statins as a part of ACS Treatment patterns

  Prescription of cholesterol lowering agents including statins as a part of ACS Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

  1 Month

Secondary Outcomes (9)

• Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns

  6 Month

• level of control of the different ACS related risk factor

  1,6,12,24 & 36 Month

• Deviation of the treatment patterns of ACS

  3 Years

• Antihypertensive as apart of ACS Treatment patterns

  6,12,24 & 36 Months

• Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns

  1 Year

Study Arms (1)

Acute Coronary Syndrom

acute coronary syndrome in a real-life setting for patients hospitalized with an ACS (i.e. STEMI, NSTEMI, unstable angina)

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-Interventional Study

Acute Coronary Syndrom

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency room (or equivalent) and diagnosed with UA, STEMI or NSTEMI.

You may qualify if:

• Patients presenting to the emergency room (or equivalent) and diagnosed with UA, STEMI or NSTEMI will be eligible to participate if all the following criteria apply:
• Provision of subject informed consent.
• Contact Order Form has been provided.
• Female and/or male aged 18 years and over.
• Diagnosis of STEMI, NSTEMI or UA using the following definitions:
• Criteria for STEMI diagnosis :
• History of chest pain/discomfort, and
• Persistent ST-segment elevation (\> 30 min) of ≥ 0.1 mV in 2 or more contiguous ECG leads or presumed new left bundle branch block (LBBB) on admission, and
• Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the upper reference limit.
• Criteria for NSTEMI diagnosis :
• (a) History of chest pain/discomfort, and (d) Lack of persistent ST-segment elevation, LBBB or intraventricular conduction disturbances, and (e) Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the upper reference limit.
• Criteria for Unstable Angina diagnosis :
• Symptoms of angina at rest or on minimal exercise, and
• (Transient) ST-T changes, and
• No significant increase in biomarkers of necrosis but objective evidence of ischemia by non-invasive imaging or significant coronary stenosis (at angiography).

You may not qualify if:

• UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or gastrointestinal bleeding or post-PCI.
• UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
• Presence of any condition/circumstance which in the opinion of the Investigator could significantly limit the complete follow-up of the patient (i.e. tourist, nonnative speaker or does not understand the local language, psychiatric disturbances).
• Already included in TOURACO observational study by another center/investigator.
• Presence of serious/severe co-morbidities in the opinion of the Investigator which may limit short-term (i.e. 6 months) life expectancy.
• If participating in any interventional clinical trial, should be adapted to each country local regulation.
• Patients with any psychotic disorders.
• Pregnancy.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Doha, Qatar

Location

Related Links

• redacted CSR synopsis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: December 5, 2017
• Study Start: December 28, 2015
• Primary Completion: April 2, 2020
• Study Completion: April 2, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

QA (1)